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Benefit Sharing Frameworks. Justifications for and against benefit sharing in human genetic research. A Report for GenBenefit (2007)

Dr. Kadri Simm

Institute for Advanced Studies on Science, Technology and Society (IAS-STS) Graz

(Austria) and Centre for Ethics, Department of Philosophy, University of Tartu (Estonia).

(Edited by Julie Cook Lucas)

To be cited as follows: Simm, Kadri (2007) Benefit Sharing Frameworks - Justifications for and

against benefit sharing in human genetic research. A Report for GenBenefit, available at:

www.uclan.ac.uk/genbenefit.

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Table of Contents

INTRODUCTION..........................................................................................................................3

REGULATORY AND RHETORICAL FRAMEWORK ................. .........................................3

ARGUMENTS AGAINST BENEFIT SHARING ......................................................................5

ARGUMENTS FOR BENEFIT SHARING ................................................................................9

THE AGRICULTURAL CONTEXT AND THE PROPERTY ARGUMENT....................................................9

THE MEDICAL CONTEXT AND THE RISK DISCOURSE .....................................................................11

THE SOCIAL/GLOBAL CONTEXT AND THE JUSTICE AND SOLIDARITY DISCOURSE..........................13

DEFINING BENEFITS ...............................................................................................................16

BENEFIT SHARING – WHOSE RESPONSIBILITY?...........................................................18

SUMMARY OF BENEFIT SHARING FRAMEWORKS............... ........................................20

CONCLUSION.............................................................................................................................22

BIBLIOGRAPHY ........................................................................................................................22

NATIONAL AND INTERNATIONAL LEGAL DOCUMENTS AND POLICY PAPERS.................................24

About the author

Dr Kadri Simm is a philosopher specialising in issues around genetics and public health,

particularly in relation to population genetic databases. She gained her PhD (“Benefit-sharing:

An Inquiry into Justification”), from the University of Tartu, Estonia in 2005. She has worked as

a specialist researcher on a number of national and international research projects focusing on the

ethical, legal and social aspects of human genomic databases and medical research.

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Introduction The following report focuses on the question of benefit sharing in human genetic research, and

more precisely, on justificatory frameworks for and against a commitment to benefit sharing.

Why should it be undertaken, and what is the reasoning behind calls for benefit sharing?

Benefit sharing pertains to the distribution of benefits but also, often implicitly, to the burdens

arising from research and development activities in human genetics. It concerns what is owed to

those people who participate in research but also to those who might not have taken part

personally but live in the same community or wider population where research is undertaken.

Results arising from research can span a wide array of potential benefits and burdens, from

improved drugs and therapies to preventive and personalised medicine, but neither benefits (nor

burdens) are necessarily linked to the health care sector. Furthermore, biomedical research in

human genetics is part of a large technological development which has global impact. This raises

concerns regarding the accessibility and availability of the results of such research on a much

wider scale, thus shifting the entire issue from the sphere of medical ethics to that of global

justice.

I will commence with briefly examining the regulatory framework for benefit sharing, noting

some international documents and guidelines that have addressed the issue. Then, before

focusing in more detail on the various justifications for benefit sharing, I will examine arguments

against benefit sharing rationale and practice. I will then proceed to explore the development of

this concept from its firstly agricultural applications, through to the specificities of the medical

context and beyond, where it becomes a tool for furthering global justice. I will conclude by

identifying issues that also need to be addressed within discussions of the justificatory

frameworks for benefit sharing, namely the content of the notion of benefit and the question of

responsibilities.

Regulatory and rhetorical framework Concerns for benefit sharing are reflected in a number of international documents. Perhaps the

most well-known is the 1992 United Nations Convention on Biological Diversity1 and the

1 United Nations, Convention on Biological Diversity (CBD), 1992; available from http://www.biodiv.org/convention/convention.shtml accessed 22.02.2007.

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ensuing Bonn Guidelines on Access to Genetic Resources and Benefit Sharing2, however these

exclude human genetic resources.

The United Nations International Convention on Economic, Social and Cultural Rights3 article

15,1b expresses, the following general point: “The States Parties to the present Covenant

recognise the right of everyone to enjoy the benefits of scientific progress and its applications”.

The “benefits of scientific progress” is a rather indefinite expression, but the thrust of the

potential right seems to refer to benefits in the most all-encompassing and all-inclusive sense.

Everyone thus appears to have a right to (enjoy) the benefits that may eventually result from

scientific activities.

The UNESCO Declaration on the Human Genome and Human Rights4, article 12a states:

“Benefits from advances in biology, genetics and medicine, concerning the human genome, shall

be made available to all, with due regard for the dignity and human rights of each individual”.

Here the concepts of human rights and human dignity take central stage, but in keeping with the

character of such grand international pronouncements, a certain vagueness remains. Exactly

what kind of regard is required by existing human rights and dignity?

The clearest identification of benefit sharing can be found in the Human Genome Organisation

(HUGO) Ethics Committee statement5 devoted specifically to the subject of benefit sharing The

HUGO Ethics Committee has been outspoken on many contentious issues around research in

genetics, and their Statement on Benefit Sharing was strongly echoed in the world of human

genetics6. The statement focuses mainly on the question of distributing the profits (also in the

non-monetary sense) that might arise from human genetic research due to the participation of

various communities. In contrast to the more general claims made in the abovementioned

2 Secretariat of the Convention on Biological Diversity, Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilisation, 2002; available from http://www.biodiv.org/doc/publications/cbd-bonn-gdls-en.pdf accessed 22.02.2007. 3 United Nations International Covenant on Economic, Social and Cultural Rights adopted and opened for signature, ratification and accession by General Assembly in December 1966, entered into force January 1976. Available from http://www.unhchr.ch/html/menu3/b/a_cescr.htm accessed 22.02.2007. 4 United Nations Educational, Scientific and Cultural Organisation (UNESCO), Declaration on the Human Genome and Human Rights; available from http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html accessed 22.02.2007. 5 HUGO Ethics Committee, Statement on Benefit Sharing (dated April 9th, 2000); available from http://www.hugo-international.org/Statement_on_Benefit_Sharing.htm, accessed 22.02.2007. 6 See for example HUGO Ethics Committee, “Genetic Benefit Sharing,” Science 290, 5489 (2000): 49; B. M. Knoppers, R. Chadwick, H. Takebe et al., “HUGO urges genetic benefit sharing,” Community Genetics 3,2 (2000): 88-92; C. Weijer, “Benefit sharing and other protections for communities in genetic research,” Clinical Genetics 58 (2000): 367-368.

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documents, the HUGO statement is exemplary because it attempts to provide a clearer and more

principled justificatory basis for the concept of benefit sharing. It offers the following rationales:

• A descriptive argument - “There is an emerging international consensus that benefits

should be shared with participants”.

• An argument from common heritage – we all share the same genome, there is a shared

interest in the genetic heritage of mankind, and the Human Genome Project should benefit

all humanity.

• Justice-based arguments – compensatory justice (compensation in return for contribution),

procedural justice and distributive justice (equitable allocation and access to resources and

goods) are all important to consider.

• Arguments about solidarity on two levels. Firstly, among a specific group of participants,

and secondly, in order to foster health for all humanity – benefits should not be limited

strictly to those participating in research.

The following analysis touches on all of these aspects of the benefit sharing rationale.

Arguments against benefit sharing Before focusing in further detail on the possible justifications for benefit sharing, it is necessary

to address arguments that dispute the application of benefit sharing frameworks to human

genetics as such. These claims are often related to an understanding that discussions of benefit

sharing legitimate attempts to commercialise and profit from the (human) genome. Such views

could be based on an understanding that genetic research is part of the larger humane project of

medicine where financial or other aspects should not compete with the overarching values like

human health and quality of life. If human genetic research is about locating genes,

understanding their functions and possibly attempting to modify these with the aim of treating or

preventing the occurrence of a gene-related disease, then it could be asked why there are such

heated debates about benefit sharing? After all, so far the understanding has been that the results

of scientific inquiries themselves suffice as the benefits that become available to the public.

Whatever has become of the concept of altruism in medical research? Why shouldn’t we

continue the honourable tradition of volunteering to help science to progress, so that future

generations may have a life with less pain and illness? Indeed, some people might even feel

offended if their honest altruistic participation was answered with the promise of a benefit.

It is possible to distinguish between two slightly different arguments against benefit sharing here.

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One focuses exclusively on the necessity and supremacy of altruism in human genetic research.

Another does not claim that talk of benefits is obsolete, or even immoral, but simply insists that

the overall benefits accruing from genetic research (advancement of medical knowledge, new

drugs etc) will be sufficient to satisfy those demands. Either way, in terms of policy, both of

these arguments essentially recommend doing nothing to change the status-quo.

The first argument, stressing the necessity of altruism in human genetic research, can be linked to

an understanding that views the debates on benefit sharing as side-effects of commercialisation.

In other words, benefit sharing is perceived as in some ways contributing to this phenomenon by

accepting the premise of trading or business-like exchange. Ruth Chadwick and Adam

Hedgecoe7 have classified the arguments against commercialisation of the human genome into

consequential and deontological camps. The former position anticipates the results of

commercialisation of the human genome to be unjust and tragic, and therefore believes this

process should be halted. Some of the perceived negative consequences could, for instance, lie in

the commercialisation of university-based research and resulting concerns about compromising

the quality of the work undertaken there. Commercial data-sharing practices could impede

scientific progress as new knowledge is rapidly patented and excluded from common resources8.

The pressure to offer genetic services on the market could affect the quality and evaluation of

these novel measures9. Also, metaphysical threats to the “ethical self-understanding of the

species” that would eventually lead to the abandonment of any moral commitment, are

highlighted as potential outcomes of commercially rampant genetic engineering and the like10.

The deontological arguments start from the premise that profiting from the human genome is

inherently immoral, as the value of the genome and genes cannot be represented in monetary or

similar trade-off terms11. Various understandings of humanist and religious accounts of human

bodily integrity and sacredness underlie this standpoint12. If genetic material is priceless, non-

commercialisable, how can its value be calculated? If it is 'sacred' how can it be bought and

7 R. Chadwick and A. Hedgecoe, “Commercialisation of the human genome,” in A Companion to Genethics, eds., J. Burley, J. Harris (Oxford: Blackwell, 2004): 334-345. 8 J. King, “Gene Patents Retard the Protection of Human Health,” GeneWatch 10, 2-3 (1996): 10-11. 9 T. Caulfield, “Regulating the Commercialisation of Human Genetics. Can We Address the Big Concerns?” in Genetic Information. Acquisition, Access, and Control, eds., A. Thompson, R. Chadwick (New York: Kluwer Academic/Plenum Publishers, 1999): 149-162. 10 J. Habermas, “The Debate on the Ethical Self-Understanding of the Species,” in The Future of Human Nature (Cambridge: Polity, 2003): 71. 11 A good overview of consequentialist and non-consequentialist arguments against gene patenting can be found in R. Macklin, “The Ethics of Gene Patenting,” in Genetic Information. Acquisition, Access, and Control, eds., A. Thompson, R. Chadwick (New York: Kluwer Academic/Plenum Publishers, 1999): 129-138. 12 D. Resnik, “The Morality of Human Gene Patents,” Kennedy Institute of Ethics Journal 7, 1 (1997): 43-61.

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sold? There remains the possibility of a gift, but gift relationships have specific characteristics

that the present commercialisation atmosphere seems not to support. The case for gift

relationships was famously stated by R. T. Titmuss who developed this approach in specifically

moral terms13. Titmuss studied blood services and compared the donor-based approach of the

United Kingdom to the paid-for services of the US (and Japan). He was interested in:

“the extent to which specific instruments of public policy encourage or discourage, foster

or destroy the individual expression of altruism and regards for the needs of others./…/ we

wanted to know whether these instruments or institutions positively created areas of moral

conflict for society by providing and extending opportunities for altruism in opposition to

the possessive egoism of the marketplace.”14

His conclusion was that the market in health care is an economic and moral failure. The donor-

based British system provided more and better quality blood than the US services where

donors/sellers were paid. Titmuss’s explanation stressed that paid-for services actually removed

choice as, “the opportunity to behave altruistically – to exercise a moral choice to give in non-

monetary forms to strangers,”15 was unavailable. The market corrupted this moral relationship of

gift-giving and of the freedom to give, transforming altruists into self-seekers16. Titmuss deemed

the economic sphere of social relations incapable of satisfying many human needs, and found the

market economy was actually responsible for the creation of a number of ‘diswelfares’17.

The applicability of the gift-relationship to genetics has been analysed, and in smaller research

projects it has been shown to play an important role, albeit perhaps containing considerably more

expectations of reciprocity than is usually acknowledged in the ideal gift-relationship rhetoric18.

But the special moral understanding underlying the gift-relationship - the voluntariness and the

somewhat equal standing of partners, are not present in the current global research situation. It is

necessary to seriously consider the possibility that medical research itself has changed

considerably and is consequently not the arena of altruism it perhaps used to be.

The exercising of gift-giving or altruism requires particular preconditions that are not presently

13 R. Titmuss, The Gift Relationship: from human blood to social policy (London: LSE Books, 1997). 14 Ibid., 59. 15 Ibid. 16 J. Le Grand, “Afterword,” in Titmuss, The Gift relationship: 334. 17 M. Hewitt, Welfare and Human Nature. The Human Subject in Twentieth Century Social Politics (New York: MacMillan, 2000): 61-63. 18 H. Busby, “Blood Donation for Genetic Research: what can we learn from donor’s narratives?” in Genetic Databases. Socio-ethical issues in the collection and use of DNA, eds., R. Tutton and O. Corrigan (New York: Routledge, 2004): 39-56.

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available. Commercialisation has meant that the main investment in health care and genomics

currently originate from the private sector, and the slice of non-profit research is getting smaller.

The medical industry has become big business; for example the pharmaceutical trade sector has

been the most profitable in the world for some time19. The stringent ethical principles

traditionally associated with medical research have thus acquired a whole new background.

Perhaps benefit sharing has become such an issue because people have realised that their

volunteering to take part in research is not matched by altruism from the research side, and

consequently compensation is required to enforce a degree of justice? It is important to

acknowledge here however, that portions of research are still sponsored by governmental or non-

profit organisations that respond more directly to public health needs and are less (or even not at

all) motivated by the potential profit-figures that are such an important consideration in for-profit

enterprises. Consequently, attention should be paid to the differing capabilities of the former

organisations in providing benefits of the scale and scope that are sometimes associated with the

pharmaceutical industry. But if big profits are made by industry, then a feeling of fairness would

demand the sharing of these profits with research participants in some form or other. The

commercialisation of research has meant that the contributions that were traditionally interpreted

within the altruistic framework characterising scientific research are increasingly viewed as

investments or calculated stakes in an arrangement primarily geared to producing profits.

In this context it seems hypocritical to suggest the centrality of the gift-relationship to developing

countries, and it is also a questionable approach in pharmaceutical industry-led research projects

in industrialised countries20. Non-engagement with benefit sharing is an option that only some

can afford and not so for populations or communities already in the midst of genetic mining. To

continue to insist that the overall benefits derived from genetic research on a global scale suffice

to meet those obligations is to choose to turn a blind eye to the stark power inequalities in today’s

world, as well as to the significant commercialisation that medical research has undergone in

recent decades. Also, too often less developed countries are sourced for purposes of producing

products aimed solely at the affluent populations of industrialised countries and consequently no

‘general’ benefits will result for the original populations.

19 HUGO Ethics Committee, “Genetic Benefit Sharing”, 49. 20 It can of course be suggested that since the citizens of industrialised countries are less vulnerable in terms of having choices available to them regarding treatment outside clinical trials, this relationship should not necessarily be conceptualised as exploitation but could be, for instance, characterised by altruism. This however needs further research, especially data on the socioeconomic background of research participants in industrialised countries.

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Lastly, a healthy pessimism towards benefit sharing seems to be justified in some cases, where

the potential outcomes of genetic research seem to be effortlessly likened to naturally occurring

resources (oil, gold etc) that are (problematically) taken for granted. Benefit sharing discussions

also tend to monopolise the problematic side of genetic research, and work to exclude significant

other issues. Sociologists of medicine have underlined the important questions of power, agency,

knowledge, personhood, risk and responsibilities that genetics has increasingly promulgated21.

Benefit sharing however, does not solve, or in most cases even relate to, these issues.

Arguments for benefit sharing

The agricultural context and the property argument

The earliest applications of benefit sharing originate from plant genomics and pertain to

agricultural resources22. This was propelled by cases where the results of research and

development activities which had been accomplished over centuries by local communities were

seized upon by big industry (as a rule originating from an industrialised country23), where the

latter has proceeded to capitalise on a certain product through patenting. Once the patent has been

granted, a local community from a developing country has no means and few resources to

challenge the situation24. Benefit sharing concerns here were not solely fuelled by claims

towards royalties but also maintained by anxieties linked to the ways in which patents will

regulate and limit access to necessary resources, thus having the potential to shape the livelihood

of many people. Within the patenting discourse the huge financial sums involved as well as the

research capabilities of large enterprises dwarfed the historical and piecemeal contributions of

local people. Benefit sharing was an attempt to acknowledge the latter and provide a more

inclusive and nuanced perspective for the assessment of those contributions.

21 See for example A. Kerr, “Rights and Responsibilities in the Genetics Era,” Critical Social Policy 23, 2 (2003): 208-226; A. Robertson, “Biotechnology, Political Rationality and Discourses on Health Risk,” Health 5, 3 (2001): 293-309; C. Novas and N. Rose, “Genetic Risk and the Birth of the Somatic Individual,” Economy and Society 29, 4 (2000): 485-513; N. Hallowell, “Doing the Right Thing: genetic risk and responsibility,” Sociology of Health and Illness 21, 5 (1999): 597-261. 22 See for example the United Nations, Convention on Biological Diversity. 23 I shall use the terms industrialised country in opposition to developing or less developed country. In the biomedical research context I agree with Ruth Macklin’s suggestion that the major difference between these two groups lies in the likelihood of the majority of the population having access to the results of successful research (Macklin, “The Ethics of Gene Patenting,” 11). 24 It is important hereby to acknowledge the fact that “community” is a very complex, ambiguous and often contested notion. See for example HUGO Ethics Committee, Statement on Benefit Sharing.

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The agricultural framework has thus furnished benefit sharing with an argument that is based on

the notion of property, recognising that the genetic resources provided for research might be

owned in some sense. Benefit sharing based on the property argument is thus mostly associated

with the struggle to end biopiracy and the patenting of various plant and animal resources without

proper regard to the contributions of local populations or without recognising biological

resources as belonging to communities or nations (whilst simultaneously insisting that these

could belong to corporations). This type of benefit sharing is characterised by the distributive

principle of desert, where local populations have a legitimate claim to a share based on their

contribution towards developing and nourishing a certain valuable biological entity, or through

the recognition of this entity as their property (and thus that they have a right to it). Another

important aspect of benefit sharing in this context pertains to a recognition that the sharing should

be done among a community or population as a beneficiary, and should not target specific

individuals.

The ownership argument and the benefit sharing arrangement built around it, is more

controversial in human genetics. Ownership here might include both the aspect of control over a

certain resource or a capability to subject this resource to commercial transaction25. Ownership

could be conceptualised as either private or common property. The UNESCO Declaration on the

Human Genome and Human Rights suggests the concept of common or shared property in the

human genome by establishing the genome as a heritage of humanity in a “symbolic sense”26.

The other possibility is that of private ownership of bodily material, but this has not been legally

established so far27. It has been argued that the holder(s) of the genetic data have not done

anything to make their so-called property valuable and therefore, at least in terms of patenting,

should not have similar rights to the researchers who have added value to it28– a sort of Lockean

understanding of mixing one’s labour with natural resources29. No conclusive compromise has

25 J. Kaye, H. H. Helgason, A. Nõmper, T. Sild, L. Wendel, “Population genetic databases: a comparative analysis of the law in Iceland, Sweden, Estonia and the UK,” Trames 8, ½ (2004): 16-17. 26 In reality, these international documents that stress the need for benefit sharing, exist side by side with others, like the World Trade Organisation’s (WTO) Trade Related Aspects of International Property Rights agreement (TRIPS), that directly contradict the ideas and principles embedded in the former. Thus while the notion of shared property has been established symbolically, parallel conventions detail contradicting private ownership rights and duties. 27 The first, infamous, case attempting to do so concluded that even if one would own the specific cells in one’s body, this did not mean that the cell lines derived from it would be owned. See Moore v. Regents of University of California, in C. Erin, “Who Owns Mo? Using historical entitlement theory to decide the ownership of human derived cell lines,” in Ethics and Biotechnology, eds., A. Dyson, J. Harris (London, Routledge, 1994). 28 R. Chadwick, K. Berg, “Solidarity and equity: new ethical frameworks for genetic databases,” Nature Review Genetics 2(2001): 320. 29 Locke of course had an important clause to the property-creation process, namely this was only allowed when ”there was still enough and as good left” (5; 26 & 33 ). It is questionable whether patenting gene functions and

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so far been reached on this issue, either philosophically or in legal terms, while patents continue

to be granted on DNA sequences.

Population biobanks provide an interesting example as regards the property argument – the

Icelandic case being the best known. The ownership question has however not been directly

dealt with in Iceland, it has only been legally established that the operator of the database is not

the owner of the resources30. In the Estonian Genome Project database the samples are an

unalienable property of the state-controlled foundation, and donors waive all rights to profits. But

with many other population biobanks it is still an open question whether the property-argument

could in principle provide a basis for a benefit sharing arrangement, be it based on the notion of

common or private property.

The medical context and the risk discourse

When benefit sharing became a relevant concern in biomedical research, it necessarily included

aspects that have traditionally characterised the relationship between the researcher and the

research participants. Although not expressed in the language of benefit sharing, compensation

for risks taken, and for time and effort spent, has for a long time been relevant in clinical trials.

The risks posed to participants in clinical trials can be serious and direct, as new medical

interventions are tried out and evaluated. Benefit sharing within this context would be a

compensatory activity geared towards those who have taken risks and accepted the possible

inconveniences that are necessary if research is to take place and possibly succeed. Without the

willingness of volunteers, research would be impossible; their participation is a necessary

component of any clinical research, be it successful or not. This traditional reciprocity in

biomedical research is increasingly conceptualised as benefit sharing.

At the same time it is important to recall that providing rewards or incentives for participants in

medical research has often been outlawed in order to ensure that no coercion or pressure is put on

potential volunteers. Much of the benefit sharing discussion, with a few exceptions31, has so far

been silent on this aspect, although it is clear that the promised benefits might have direct

sequences does leave enough for others. J. Locke, “Second Treatise on Government,” in Two Treatises of Government, ed., P. Laslett (Cambridge: Cambridge University Press, 1996). 30 Kaye et al., Ibid., 18. 31 Exceptions being here for instance HUGO Statement on Benefit Sharing (stating: “the actual or future benefits discussed should not serve as an inducement to participation”), and National Bioethics Advisory Commission, Ethical and Policy issues in International Research: Clinical Trials in Developing Countries; available from http://www.georgetown.edu/research/nrcbl/nbac/pubs.html accessed 22.02.2007.

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relevance to the participants’ decisions. But the possibility that the benefits on offer may be the

strongest factor influencing decisions about consent, whether these decisions are made

communally or individually, and perhaps to the detriment of other concerns, should not be

overlooked.

As pointed out in the HUGO Statement on Benefit Sharing, other justifications besides the

compensatory logic can ground this principle in the biomedical sphere. An influential UK

bioethics body, the Nuffield Council on Bioethics has published a report, The Ethics of Research

Related to Health Care in Developing Countries32. The document outlines many principles that

the Council argues should regulate the relationship between researchers and

patients/communities. More specific examples of moral duties that can be relevant as regards

benefit sharing are:

• Duty not to exploit the vulnerable. This refers to the duty to abstain from taking advantage

of the unequal circumstances of power, resources and opportunities in the world; a

negative duty to refrain.

• Duty to alleviate suffering. This points to the necessity of providing benefits to those in

need, a sort of positive requirement for those who have the power to act in alleviating

suffering, based on the concepts of solidarity and justice33.

While compensatory justice is an appropriate rationale for sharing benefits among a clearly

identifiable group of participants, the duties outlined above are in principle significant also in a

wider context. These moral obligations can be employed to provide a basis for benefit sharing on

a more inclusive and expanded level.

Until a decade ago benefit sharing in the sphere of medicine had been a rather local instrument,

based primarily on compensatory logic. Although pharmaceutical companies have been global

organisations for decades, research projects had still been limited to, and largely characterised by,

a close relationship between a research agency and the local community or individual patients.

This bounded nature of the research setting and the more or less identifiable body of relevant

actors and participants meant that benefit sharing was a relatively specific, finite event. It was

possible to ascertain those taking part and assess their claims within the medical, compensatory

framework. The Human Genome Project however, is an enterprise on a much larger scale.

Genetic research, for example, as undertaken in the form of genetic databases, swells the number

32 Nuffield Council on Bioethics, The Ethics of Research Related to Health Care in Developing Countries; available from http://www.nuffieldbioethics.org/publications/pp_0000000013.asp accessed 22.02.2007. 33 See Chadwick and Berg, “Solidarity and Equity…”: 318-321; also Nuffield Council on Bioethics, The Ethics of Research Related to Health Care in Developing Countries.

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of participants considerably, and also blurs the very concept of participant, as genetic information

is by nature shared. Those potentially affected by the research may be a much larger group of

people than those who are participating in it, in the traditional sense of that word. In addition, the

intergenerational nature of genetic information does not allow for an easy delineation between

those who are directly participating in research and those that it might subsequently affect.

Increasingly, there is a consensus in human genetic research that to limit the sharing of benefits

only to those who were directly involved is not justified, and this already marks a shift away from

a strictly reciprocal model of distributive justice. Access to successful results of research in

terms of community or population could increasingly become an important factor in determining

the justice of the research setup34. Large genetic databases also complicate benefit sharing, as

unexpected benefits and harms may arise when new research is undertaken.

Arguments for the application of the concept of solidarity in benefit sharing have also been

made35, so that benefits arising from research would not be shared based on the principles of

medical ethics, stressing compensation for risks taken, but based instead on principles of social

justice. It is this line of thought, which links benefit sharing to issues of justice, and disconnects

the concept from the particularities of the medical sphere (in terms of justifications and general

principles) that adds a new angle to the benefit sharing discussion.

The social/global context and the justice and solidarity discourse

Solidarity is an elusive notion which is difficult to capture, although most would agree that it

characterises indeterminate feelings of closeness, and perhaps even of caring, in relation to the

interests of groups of other people. Solidarity as identified in communitarian discourses would

be a suitable principle for benefit sharing that focuses on a certain limited community or

population, but it is also clear that reliance on solidarity could create tension with the

compensatory approach to benefit sharing, especially if some participants have accepted more

direct risks than others.

The larger the number of participants in research, the more significant the concept of solidarity

becomes in benefit sharing. The HUGO Statement on Benefit Sharing insists on the principle of

solidarity on several occasions. Firstly, there is group solidarity among those participating in

research or sharing genes, and HUGO insists that benefit sharing should not be limited to those

34 G. Williams, D. Schroeder, “Human genetic banking: altruism, benefit and consent,” New Genetics and Society 23, 1(2004): 89-103. 35 HUGO, Statement on Benefit Sharing.

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who participated, as this would be “inconsistent with solidarity”. Although small scale research

projects could in principle ground benefit sharing within traditional medical frameworks (e.g.

compensating for risks taken, taking steps to avoid exploitation etc.), the fact that genetic

information is shared among people means that participation by some will “automatically”

involve their families. Medical and legal frameworks that have focused on the person as a

separate identity, “whose interests - and records - can neatly be separated from those of their

families,”36 are challenged by genetics where the dichotomies of self/other might not be directly

applicable.

The relevance of solidarity increases further with regard to large community or population based

research projects. The HUGO statement insists that health should be promoted universally and

that affluent nations and commercial entities are “to foster health for all humanity”37. Fostering

health here does not necessarily mean sharing the benefits of specific research projects but could

entail, for example, increasing the research focus on diseases that are prevalent in poorer

countries, so that the whole of humanity can benefit from the technology and know-how. Thus in

this second instance solidarity covers a much larger ground, and it becomes inappropriate to talk

about groups, when solidarity with humanity is intended. A notion of solidarity that stretches

beyond the limited obligations of traditional medical research projects is a useful conception that

would allow for wider inclusion of those affected or in need38.

Thus increasingly benefit sharing rhetoric has been voiced not only in the context of specific

research projects but has addressed concerns arising from the availability of the results of genetic

research on a global scale, insisting that all of humankind should be involved in this sharing39.

The introduction of universal benefit sharing entails several important changes to the justification

and employment of the concept in comparison with previous applications. The aim here is to

36 C. M. Kaveny, “Jurisprudence and Genetics,” Theological Studies 60, 1 (1999): 135. 37 HUGO, Statement on Benefit Sharing. 38 Although there are conceptual problems with employing solidarity in a global context (see K. Simm, “An Argument for Benefit-Sharing Through Solidarity,” Social Justice in Context, Vol.2 (2006): 47-64.). It has been suggested that modern solidarity will be ultimately based on merging the universal human rights discourse and citizenship rights. This might be an appropriate combination for a type of solidarity that benefit sharing would need – inclusive of respect towards individual rights, as well as attentive to shared identities and the affections characterizing our close associations. B. Turner, C. Rojek, Society and Culture. Principles of Scarcity and Solidarity (London: Sage Publications, 2001): 207. 39 See for example L. Mansur, “Gene Discovery, Ownership and Access for Developing Countries in the Era of Molecular Genetics,” Electronic Journal of Biotechnology 5, 1 (2002); available from http://www.ejbiotechnology.info/content/vol5/issue1/issues/05/) accessed 22.02.2007; M. G. de Ortứzar, “Towards

a Universal Definition of ‘Benefit sharing’,” in Populations and Genetics: Legal and Socio-Ethical Perspectives, ed. B. M. Knoppers (Leiden: Martinus Nijhoff, 2003): 473-486; T. Schrecker, “Benefit sharing in the New Genomic Marketplace,” in Knoppers, ed., Populations and Genetics: 405-422.

15

engage with the challenges of global justice, thus responding not only to circumscribed concerns

about distinct research projects but with the way that access to research results is provided or

denied to everyone else. These concerns are sustained by the way in which research results have

been largely unavailable to the majority of the world population. This is due to various factors –

e.g. the high cost of novel drugs and therapies, and the patenting of research results that limits

access to them, as well as the way research priorities are skewed towards the interests of affluent

nations, and disproportionately little research is conducted into illnesses that are prevalent among

the populations of developing countries.

Therefore one of the most influential arguments behind universal benefit sharing refers to large-

scale exploitation, to past and present inequalities of power and resources in the world. These

inequalities are capitalised upon by big international corporations as well as powerful nation-

states, creating and enforcing further injustice between developing and industrialised countries.

Both in terms of genetic and non-genetic resources there is a shared feeling of unfairness when

richer countries exploit poorer ones40. Insisting that the human genome is common property41 or

that genetic databases should be global public goods42 – all these different arguments have in

common a concern that the present biotech revolution will turn out to increase the inequalities of

the world, and enlarge the so-called North-South divide43.

For these diverse and substantial reasons, the concept of universal benefit sharing would have to

depart from the more contextualised rationales of sharing which characterise this undertaking

within non-human genetics and traditional medical research, moving towards the inclusion of

humanistic ideals such as responding to human needs and respecting the principle of equality.

This is why concepts like solidarity have been put forward to provide an alternative rationale for

distributing the benefits in a more inclusive manner. The UNESCO Universal Declaration on the

Human Genome and Human Rights has recognised the fundamental unity of humankind

manifested in our sharing the genome, and has suggested the linkage of this unity to the concepts

of human dignity and diversity.

40 K. Berg, “The Ethics of Benefit-Sharing,” Clinical Genetics 59 (2001): 240-243. 41 To quote Ortứzar: “ there is no reason to confer benefit exclusively on the population which is the subject of the research /…/ all benefit derived from genetic research on populations should be available to anyone in need of the health improvement offered by it.” Ortứzar, “Towards a Universal Definition of ‘Benefit sharing’ ”: 478. 42 HUGO Ethics Committee, Statement on Human Genomic Databases; available from http://www.hugo-international.org/Statement_on_Human_Genomic_Databases.htm accessed 22.02.2007. 43 World Health Organisation, Genomics and World Health, 2002; available from http://whqlibdoc.who.int/hq/2002/a74580.pdf accessed 22.02.2007.

16

Defining benefits An issue that cannot be addressed in this report at length but that has significant implications for

benefit sharing discussions pertains to what exactly are or could be the benefits? Clarification of

the potential categories of benefits would be useful in consolidating the debate. The HUGO

Ethics Committee has expressed in its Statement on Benefit Sharing the following:

“A benefit is a good that contributes to the well-being of an individual and/or a given

community (e.g. by region, tribe, disease-group...). Benefits transcend avoidance of harm

(non-maleficence) in so far as they promote the welfare of an individual and/or of a

community. Thus, a benefit is not identical with profit in the monetary or economic sense.

Determining a benefit depends on needs, values, priorities and cultural expectations.” 44

Benefits put forward by scientists, as well as the pharmaceutical industry, patients, investors and

public health officials span a wide array of potentially valued “goods”; from improved health and

better science to financial gains and wider social benefits. What lies behind the notions of the

benefits and burdens of genetic research that are deployed in various discussions? The HUGO

definition is rather vague, and is probably intended to be such for the purposes of maximum

inclusiveness, but below is an outline of issues that have been named by various international

actors.

Most debates have focused on health-related benefits, but increasingly benefits can be defined in

other terms – e.g. research cooperation, training of local researchers etc. Admittedly, in many

cases the question is not about “handing out” benefits, but rather in allowing access to various

products and technologies. This access is currently severely restricted for many poor countries

for various reasons. There is of course the issue of finances, as access to drugs, therapies,

technologies and know-how is restricted by patents or high costs. But it is also a larger problem

of limited capabilities – in many instances knowledge, innovation and novel practices are simply

unusable in the deprived conditions prevalent in many countries.

44 HUGO, Statement on Benefit Sharing.

17

Table 1: Types of Benefits Health benefits Commercial/economic

benefits

Scientific benefits

Individual level Designer drugs and other

individual aspects of

“personalised medicine”

Profits to the investors

Communal

level

Relief to disease-affected

populations etc

Non-medical benefits

to communities;

capability-building

National, state

level

Efficient health care

services, policy planning

etc

Development of

biotech and related

sectors, new jobs etc;

capability-building

Global level Eradication of diseases

etc

Non-instrumental

knowledge:

development of

science and

gaining of new

information as a

value in itself,

regardless of

whether it is

useful to humans

This table is illustrative rather than exhaustive and no judgment is presently made concerning the deliverability of

these benefits.

Is benefit sharing still a concern when there are no scientific results after the research project has

been completed? What becomes of benefit sharing when there are no benefits, when research is

unsuccessful? It has been argued that the very idea of benefit sharing presupposes that there are

benefits available45. But if benefit sharing is interpreted as an exercise and practice of reciprocity

and fairness, this might not necessarily be so. Benefit is not identical with profit, or even with

medical goods. Capability-building, for example through training local competencies, can be part

of the research process, and is in some sense independent from research results. Even if no

products result, valuable information that can guide further research is most likely still achieved.

This issue is closely linked to how benefits are defined – whether they are determined before the

start of research and cannot be renegotiated; whether they are defined in terms of outcomes

directly originating from the research, or can anything be defined as a benefit by participants or a

community (e.g. something essentially unrelated to the potential outcomes of research)?

Ultimately, benefit sharing might have strong procedural justice qualities in providing for a sense

of inclusion and attention that would be of distinct relevance compared to that of distributive

justice.

45 Berg, “The Ethics of Benefit-Sharing,” 242.

18

Benefit sharing seems to be fuelled on the one hand by feelings of injustice emerging from

inequalities of power between the global medical and pharmaceutical industry and the resource-

rich less developed countries; on the other hand the scene has been influenced by the often over-

hyped visions of grand future developments. A benefit sharing framework could include a

number of principles and not be predefined by a certain limited set of concerns that are to be

applied universally46. In such a case, the fact that direct benefits do not result has in principle no

relevance to the benefit sharing arrangement. It could be a moral obligation independent of

actual research results.

Benefit sharing – whose responsibility? Another important question for the justificatory framework of benefit sharing is that of

responsibilities. Who should take care of these practices, or be held accountable if benefits are

not shared? The responsibilities ensue from how benefit sharing as a moral requirement is

reasoned for in particular instances. Within specific research projects concerned with sharing

benefits within a limited group of stakeholders, the responsibilities are easier to settle. The

reciprocity which characterises clinical trials or other research events points to the appropriate

duties of researchers and sponsors47. The risk discourse delineates a recipient community, and

those responsible for creating these risks have a duty to compensate within the reciprocal setting.

Increasingly, international and national guidelines have stressed the duty to provide post-trials

benefits (usually in the form of medical care and drugs) to participants, and research projects

would need to outline these schemes before commencing48.

In comparison with the medico-ethical regulations stressing mostly the responsibilities of

sponsors and researchers, the Nuffield Council on Bioethics has added another subject. The

46 G. Laurie, K. G. Hunter, “Benefit sharing and public trust in genetic research,” in Blood and Data. Ethical, Legal and Social Aspects of Human Genetic Databases, eds., G. Árnason, S. Nordal, V. Árnason (Reykjavik: University of Iceland Press and the Centre for Ethics, 2004): 327. 47 For example, Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, guidelines 10 and 21.NBAC, Ethical and Policy issues. Available from http://www.cioms.ch/frame_guidelines_nov_2002.htm, accessed 22.02.2007. 48 World Medical Association, Helsinki Declaration, principle 30. Available from http://www.wma.net/e/policy/b3.htm accessed 22.02.2007; European Group on Ethics in Science and New Technologies, Ethical Aspects of Clinical Research in Developing Countries, available from http://www.europa.eu.int/comm/european_group_ethics/docs/avis17_en.pdf accessed 22.02.2007. Similar regulations have been accepted by various national bodies e.g. the Brazilian National Health Council, Resolution 196/96 - On Research Involving Human Subjects, 1996, available from http://coralx.ufsm.br/prpgp/pdf/resolucao_196_en.pdf accessed 22.02.2007.

19

Council has stressed that it is the responsibility of governments to provide their citizens with the

needed health care products and services, and such duties cannot reside with sponsors or

researchers. The Council states: “responsibility for making a vaccine, treatment or other

intervention available will not lie solely with any one group. If a national government has agreed

to allow a trial to take place, it presumably accepts some responsibility to act on the results”49.

The Council insists that providing citizens with health care products and services in general

cannot be an issue solved through the benefit sharing schemes of specific research projects. Here

the Council has differentiated between the traditional medical compensatory framework applied

to organizers of research and direct participants, and the larger issue of providing health care for

populations, an issue that benefit sharing as a social/global justice framework tries to engage

with. The Council relies on the conventional logic of international relations assigning the rights

and responsibilities of states before their citizens.

However, the HUGO Statement on Benefit Sharing has implied that perhaps these responsibilities

should be rethought, by suggesting that medical enterprises might have special moral obligations.

This is based on an understanding that human health is of fundamental value, and access to health

care is a basis upon which much else in life depends. Illnesses often diminish the choices we

have in life, thus linking this issue to the principle of equal opportunities50. While the fulfilment

of this principle has traditionally been the responsibility of governments, the HUGO statement

introduces an alternative possibility that acknowledges the increasing influence and power that

non-state actors have in our globalising world.

When universal benefit sharing is based on the language of human rights – e.g. everyone has the

right to benefit – then responsibilities lie with those who are obligated to fulfil and guard such

rights. In terms of universal sharing, the “international community” (meaning international

organisations) has been called upon to take redistribution into their hands51. It has been proposed

that pharmaceutical companies sponsoring research should take an active part in benefit sharing:

for example the HUGO Ethics Committee has suggested that companies should set aside 1-3% of

annual net profit to support health care infrastructures and/or humanitarian efforts52. Various

partnerships and collaborative agreements between governments, research agencies, NGOs and

others are possible ways to further these activities.

49 Nuffield Council, The Ethics of Research Related to Healthcare in Developing Countries, 122. 50 N. Daniels, Just Health Care, (Cambridge: Cambridge University Press, 1985). 51 Ortứzar, “Towards a Universal Definition of ‘Benefit sharing’,” 481. 52 HUGO, Statement on Benefit Sharing.

20

Summary of Benefit Sharing Frameworks Below is an introductory table of major justificatory arguments for and against benefit-sharing.

This overview is useful in tracing and substantiating concerns for benefit sharing, especially in

terms of the history of the concept and the various reasonings behind it.

As we have seen, a number of benefit sharing arguments function only in specific contexts,

whereas others have relevance universally. Compensation for risks taken is important where

smaller research projects are concerned, whereas fairness gains significance in cases of successful

drug development for diseases which are prevalent in the poorer areas of the world. Some of the

uncertainties and doubts that have accompanied the benefit sharing discussion in genetic research

might have to do with the fact that the arguments based on global injustice might, for example,

not fit so well into the research frameworks of industrialised countries. For example, altruistic

participation might still be a possibility in industrialised countries, whereas a similar rationale is

much more difficult to accept when research is undertaken in developing countries where the

inequalities of power and the local deprived conditions limit the acceptability of this principle.

21

Table 2: Benefit Sharing Frameworks Property

argument

Compensation

argument

Solidarity argument

Background Agriculture and

more widely

plant/animal

genomics

Biomedical

research and

especially

clinical trials

Social/global justice

concerns, human rights

discourse

Benefit sharing

justified

because….

a) Participants

have contributed

their private

property (genes)

b) Participants

have contributed

common

property (human

genome)

Participants have

accepted certain

risks, have

contributed their

time and effort

and should

receive benefits

as compensation

Participants (either direct or

indirect) have needs and

rights, the sharing of

benefits of genetic research

can and should address

these.

Benefit sharing

not justified

because….

People don’t

have property

rights in their

genes

Medical research

should be based

on altruism

General benefits accruing

from the developments in

genetic research suffice.

It is also important to acknowledge the way in which the arguments used to justify benefit

sharing determine who the benefits should be shared with. In other words, certain justifications

necessarily exclude or include specific groups or communities. For example, when we consider

the genome to be the common property of humanity, the sharing should be done among all

human beings. On the other hand, when benefit sharing is conceptualised as compensation for

voluntarily taken risks, it would seem unfair to share benefits with those who have not taken any.

Justifications for benefit sharing can be contradictory: arguments from solidarity would produce a

different benefit sharing arrangement to one based on taking direct medical risks. Many would

refer to a certain ‘gut-feeling’ that in principle benefits are due in return for a contribution, but in

the complexities of genetic research these are in many cases very hard to establish. Expressing

this feeling can result in quite different philosophical and political principles pertaining to

distributive justice, solidarity, human dignity and others.

22

Conclusion Traditionally, biomedical research has been concerned with sharing benefits with those more or

less directly involved in the research. The practice of benefit sharing, especially in agriculture,

has introduced a different perspective that recognises the contributions of communities and

populations. The issue is further complicated in human genetics as genetic information is by

nature shared, thus involving individuals and communities who might not have participated in

research in the traditional sense. Research is increasingly associated with for-profit companies

and practices, and other aspects of this large scale venture have given credence to concerns of

political, social and economic origin. Of course in principle, “genetic research on a global scale”

is still made up of specific research projects, but calls for benefit sharing in a universal sense ask

us to look beyond these specific projects and assess the impact of the entire phenomenon

inclusive of factors outside the regulated medical sphere.

In conclusion, I suggest that it is not necessary to settle on one justificatory framework and

disregard all the others. Local contingencies have an important role to play in deciding specific

benefit sharing arrangements and ensuring that the interests and needs of those involved are heard

and accounted for. On the other hand, the existence of a larger framework is also necessary –

firstly in order to provide a frame of reference and a rationale for insisting upon and taking up

specific benefit sharing schemes, and secondly, in relation to universal benefit sharing, to

approach the structural causes of skewed biomedical research priorities and tackle the continuing

effects of colonization and global inequalities.

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